Cytalux™ for Prostate Cancer

Recruiting at 2 trial locations

Overseen By Jennifer Lehman, RN

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Clinton Bahler

Disqualifiers: Extraperitoneal approach, Anaphylactic reactions, Allergy to pafolacianine, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

15 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is being done to compare how much using Cytalux™ (pafolacianine) with NIR (Near InfraRed) fluorescent imaging improves the detection of malignant (growing in an uncontrolled way) tissue in adult subjects undergoing prostatectomy and lymph node dissection for biopsy confirmed prostate cancer. The U.S. Food and Drug Administration (FDA) has approved the targeted imaging agent pafolacianine (Cytalux) for use in ovarian cancer (2021) and lung cancer surgery (2022.)

Will I have to stop taking my current medications?

The trial requires participants to stop taking folate or folic acid supplements at least 48 hours before receiving the study agent. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

How does the drug Cytalux™ differ from other prostate cancer treatments?

Cytalux™ is unique because it is designed to help surgeons see cancerous tissue more clearly during surgery by making it glow, which is different from traditional treatments that focus on shrinking or killing cancer cells directly. ^{1 2 3 4 5}

Research Team

Clinton Bahler, MD

Principal Investigator

Indiana University

Eligibility Criteria

This trial is for adults with biopsy-confirmed prostate cancer who are undergoing prostatectomy and lymph node dissection. Details about specific inclusion or exclusion criteria are not provided, but typically participants must meet certain health standards and not have conditions that would interfere with the study.

Inclusion Criteria

I am a man aged 18 or older.

Signed and dated informed consent form

My prostate cancer is aggressive and may have spread beyond the prostate.

Exclusion Criteria

My surgeon will operate outside the peritoneal cavity.

Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject

History of anaphylactic reactions to products containing indocyanine green

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo laparoscopic radical prostatectomy with NIR imaging using pafolacianine

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

Treatment Details

Interventions

• CYTALUX™

Trial Overview The trial is testing Cytalux™ (pafolacianine) used alongside NIR fluorescent imaging to see if it helps better identify cancerous tissue during surgery in patients with prostate cancer. The FDA has previously approved this agent for ovarian and lung cancer surgeries.

Participant Groups

Group I: Pafolacianine injection and surgery Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Clinton Bahler

Lead Sponsor

Trials

3

Recruited

80+

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

On Target Laboratories

Collaborator

Trials

2

Recruited

30+

On Target Laboratories, LLC

Industry Sponsor

Trials

8

Recruited

470+

Findings from Research

New treatments for advanced prostate cancer are on the horizon, including hormonal therapies like Abiraterone and MDV3100, which target hormone pathways to slow cancer growth.

Innovative options such as the chemotherapy Cabazitaxel and the cellular vaccine Sipuleucel-T are being explored, alongside anti-angiogenic drugs and new radioactive treatments, indicating a multi-faceted approach to combatting this challenging disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New drugs at the horizon for men with prostate cancer]. Shabafrouz, K., Bauer, J., Berthold, DR.[2010]

In the phase 3 HERO trial involving patients with advanced prostate cancer, relugolix showed superior sustained testosterone suppression compared to leuprolide over a 48-week period.

Relugolix also allowed for faster testosterone recovery after treatment discontinuation and was associated with a 50% reduction in major adverse cardiovascular events (MACE), highlighting its potential safety benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 3 HERO Trial Finds Relugolix to Be Superior to Leuprolide in Prostate Cancer. Slater, H.[2021]

Prostate cancer is a common malignancy in men over 50, primarily presenting with urinary issues, and is mostly treated effectively with prostatectomy or irradiation when localized, leading to a good prognosis.

Hormonal manipulation is the main treatment for metastatic prostate cancer, with 70-80% of patients responding to therapies like orchiectomy and LHRH analogs for up to three years, although responses diminish significantly after relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of prostate cancer. Korman, LB.[2005]

In a trial involving advanced metastatic prostate cancer, the combination treatment of the LHRH agonist buserelin and cyproterone acetate showed no significant difference in response rates, progression time, or survival compared to orchidectomy, indicating similar efficacy among the treatment options.

The use of cyproterone acetate alongside buserelin was aimed at preventing disease flare-ups and reducing side effects like hot flushes, but ultimately did not improve outcomes compared to surgical removal of the testes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maximum androgen blockade using LHRH agonist buserelin in combination with short-term (two weeks) or long-term (continuous) cyproterone acetate is not superior to standard androgen deprivation in the treatment of advanced prostate cancer. Final analysis of EORTC GU Group Trial 30843. European Organization for Research and Treatment of Cancer (EROTC) Genito-Urinary Tract Cancer Cooperative Group. de Voogt, HJ., Studer, U., Schröder, FH., et al.[2019]

In a study involving 304 patients with advanced prostate cancer, there was no significant difference in overall and progression-free survival between those treated with Zoladex alone and those treated with Zoladex plus flutamide.

The combination treatment of Zoladex and flutamide resulted in a higher response rate and quicker relief of bone pain, but it also led to more side effects, suggesting that the combination may not provide a clear advantage over Zoladex alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zoladex with or without flutamide in the treatment of locally advanced or metastatic prostate cancer: interim analysis of an ongoing PONCAP study. Italian Prostatic Cancer Project (PONCAP). Boccardo, F., Decensi, A., Guarneri, D., et al.[2019]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

[New drugs at the horizon for men with prostate cancer]. [2010]

2. United States pubmed.ncbi.nlm.nih.gov

Phase 3 HERO Trial Finds Relugolix to Be Superior to Leuprolide in Prostate Cancer. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Treatment of prostate cancer. [2005]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Maximum androgen blockade using LHRH agonist buserelin in combination with short-term (two weeks) or long-term (continuous) cyproterone acetate is not superior to standard androgen deprivation in the treatment of advanced prostate cancer. Final analysis of EORTC GU Group Trial 30843. European Organization for Research and Treatment of Cancer (EROTC) Genito-Urinary Tract Cancer Cooperative Group. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Zoladex with or without flutamide in the treatment of locally advanced or metastatic prostate cancer: interim analysis of an ongoing PONCAP study. Italian Prostatic Cancer Project (PONCAP). [2019]